All the scientific articles are gathered together as a primary part of the clinical evaluation. MEDDEV 2.7/1 is the most important guideline for the literature search under the MDR. In MEDDEV 2.7/1 rev. 4, A5 says about the literature search and literature review protocol, key elements.
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Through the literature search, we can find literature on the device under evaluation that includes the equivalent device and the state of the art, including alternative examination and treatment methods.
MEDDEV 2.7/1 Revision 4, Annex 5 describes the most important feature to remember when documenting the literature search. In it, the guideline requires the objective of the literature search to be documented. That is, make available data on the device under evaluation that includes device model and name, important data for the risk management process, providing data for the evaluation of the benefit/risk profile, a general review of the current safety specifications, providing data on benchmark devices, Several MDCG documents are also available on the topic of the clinical evaluation, but they do not describe how to execute and document the literature search for the clinical evaluation.
Incomplete documentation of the literature search was not taken, because that led to unnecessary quarries. The MDCG documents explicitly require notified bodies to review the literature search documents.
Search terms, databases used, inclusion and exclusion criteria, exclusion of duplicates, literature review procedure and documentation, and search methods. At least two essential criteria we should use in our literature search based on MEDDEV 2.7/1 Revision 4 require: we need state of the art search to demonstrate current methods for your device and to evaluate your device in comparison; we need the detailed statements (or equivalent device) to demonstrate the safety, performance, and clinical benefit of your medical device.
The PICO method is mentioned in the MEDDEV 2.7/1 Revision 4 when trying to find search criteria for the state of the art. Many databases are available now. We can use multiple or more databases to minimize bias in the literature review. e.g., Medline, PubMed, Trip, Cochrane Central Trials Register. When doing a literature search, we can use Boolean operators to narrow down our search. The most commonly used operators are AND, OR, NOT, and quotation marks and round brackets are also useful for better result.